Acarbose for Kidney Cancer

Overseen By Arnab Basu, MD,MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Must not be taking: Steroids, Immunosuppressants, CYP3A4/5 inducers

Disqualifiers: Immunodeficiency, Autoimmune disease, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerability of acarbose (a medication typically used to treat diabetes) when combined with standard immunotherapy treatments for advanced kidney cancer. Researchers are testing several combinations, including acarbose with drugs such as ipilimumab, nivolumab, pembrolizumab, lenvatinib, everolimus, and cabozantinib. This trial is suitable for individuals with advanced renal cell carcinoma (a type of kidney cancer) who have not received systemic treatment in the last three weeks and have cancer that cannot be surgically removed. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot use certain drugs that strongly affect liver enzymes (CYP3A4/5 inhibitors or inducers) within 7 days before starting the trial. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that acarbose might slow kidney cancer growth and strengthen the immune response against tumors. Studies in mice have demonstrated these benefits, especially when combined with current cancer treatments. However, research in humans continues.

Acarbose, commonly used to treat diabetes, is generally well-tolerated. People taking acarbose might experience mild side effects like digestive issues, but serious side effects are rare.

This trial is in an early stage, focusing on the safety of acarbose when combined with immunotherapy for kidney cancer. While early results appear promising, further research is needed to confirm its safety for cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Acarbose for kidney cancer because it takes a novel approach by adding a metabolic component to the treatment regimen. Unlike current standard treatments, which primarily involve immunotherapy or targeted therapy, Acarbose is primarily known as a diabetes medication that slows down carbohydrate absorption, potentially affecting cancer cell metabolism. This unique mechanism could enhance the effectiveness of existing cancer therapies like Ipilimumab, Nivolumab, Pembrolizumab, Lenvatinib, Everolimus, and Cabozantinib by disrupting the energy supply of cancer cells. By integrating Acarbose, researchers hope to boost the overall efficacy of these regimens and tackle cancer cells resistant to traditional therapies.

What evidence suggests that this trial's treatments could be effective for kidney cancer?

This trial studies Acarbose in combination with various treatments for kidney cancer. Research has shown that Acarbose, when used with other treatments, can slow kidney cancer growth. It helps shrink kidney tumors by weakening cancer cells, making them less likely to survive and grow. Acarbose also strengthens the body's immune system, aiding in the fight against cancer. Studies in mice suggest that this drug, when combined with current kidney cancer treatments, could lead to better outcomes. While these findings are promising, further research is needed to confirm its effectiveness in humans. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced kidney cancer who haven't had systemic therapy in the last 3 weeks. They must have a certain level of physical ability, agree to use contraception, and have specific organ function levels. Excluded are those with treated diabetes, psychiatric issues affecting study cooperation, recent major surgery or other treatments, severe allergies to acarbose or standard care drugs.

Inclusion Criteria

I started bone-strengthening treatment at least 2 weeks ago.

I agree to use birth control from the start of the study drug until 120 days after the last dose.

You have a condition that can be measured by the doctor using a specific assessment tool.

Exclusion Criteria

I have not received a live virus vaccine in the last 30 days.

I am currently being treated for an infection.

My diabetes is managed with medication and my HbA1c is below 8.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of immunotherapy and acarbose for metastatic renal cell carcinoma

2 years

Every 3-6 weeks depending on treatment regimen

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acarbose

Trial Overview The trial tests the safety and effectiveness of acarbose tablets when added to standard immunotherapy in treating advanced renal cell carcinoma. Participants will receive this combination treatment and be monitored for how well they tolerate it and any signs of improvement.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 Intervention

Ipilimumab (1 mg/kg) IV q3wks + Nivolumab (3mg/kg) IV q3wks + Acarbose (upto 100 mg PO TID) followed by Nivolumab 480 mg IV q4 wks + Acarbose (upto 100 mg PO TID) OR Pembrolizumab 200 mg IV q3 wks or 400 mg IV q6 wks + Lenvatinib (up to 20 mg PO Daily) + Acarbose (upto 100 mg PO TID) \[ Frontline/Refractory pts\] OR Lenvatinib (upto 18 mg PO daily) + Everolimus (upto 5 mg PO Daily) + Acarbose (upto 100 mg PO TID) \[ Refractory pts\] OR Cabozantinib (upto 60 mg PO Daily) + Acarbose (upto 100 mg PO TID) \[Refractory pts\]

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7601245/

The Antidiabetic Agent Acarbose Improves Anti-PD-1 and ... We found that acarbose slowed kidney cancer growth and promoted protective immune responses. In combination with either an immunotherapy or a targeted therapy ...

2. mdpi.com mdpi.com/2072-6694/12/10/2872/review_report

The Antidiabetic Agent Acarbose Improves Anti-PD-1 and ... Major findings of the study show that Acarbose induced reduction in primary renal tumor growth, which is associated with reduced tumor cell viability and ...

3. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/renal-cancer/125245-the-antidiabetic-agent-acarbose-improves-anti-pd-1-and-rapamycin-efficacy-in-preclinical-renal-cancer.html

The Antidiabetic Agent Acarbose Improves Anti-PD-1 and ... Our findings in mice suggest that combining acarbose with current RCC therapeutics may improve outcomes, warranting further study to determine ...

4. researchgate.net researchgate.net/publication/344501052_The_Antidiabetic_Agent_Acarbose_Improves_Anti-PD-1_and_Rapamycin_Efficacy_in_Preclinical_Renal_Cancer

The Antidiabetic Agent Acarbose Improves Anti-PD-1 and ... Another study showed that the antidiabetic drug acarbose improved rapamycin efficacy in metastatic kidney cancer, and the combination ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33036247/

The Antidiabetic Agent Acarbose Improves Anti-PD-1 and ... We found that acarbose blunted postprandial blood glucose elevations in lean, nondiabetic mice and impeded the growth of orthotopic renal tumors.

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/353195

Acarbose in Combination with Standard Therapy in Metastatic ... The purpose of this study is to determine the safety and tolerability of acarbose in combination of immunotherapy based standard of care therapy in advanced ...

7. researchgate.net researchgate.net/figure/Acarbose-impedes-growth-of-renal-tumors-A-Primary-renal-tumor-burdens-over-time_fig2_344501052

Acarbose impedes growth of renal tumors. (A) Primary ... Although its mechanism for metastasis inhibition is unclear, studies found that acarbose slowed kidney cancer growth and promoted protective immune responses [ ...